Senseonics (NYSE:SENS) announced today that it received CE mark for the next-generation Eversense E3 CGM system.
Germantown, Maryland-based Senseonics offered a previous-generation continuous glucose monitor (CGM) with a 90-day wear time. Its next-generation Eversense E3 can be used for up to six months (180 days).
Europe already had a 180-day Senseonics CGM system available (Eversense XL), but the next-generation Eversense E3 has a number of improvements on the XL, including reduced calibrations, enhanced survivability and non-adjunctive use, meaning fingersticks aren’t necessary for dosing decisions.
Now approved in Europe, the Eversense E3 received FDA approval in February. Ascensia Diabetes Care, Senseonics’ global commercial partner, then launched the system in the U.S. on April 4 and the first patient received the E3 implantation that same week.
Ascensia will make the Eversense E3 available in Europe from the third quarter of 2022, according to a news release. It will be distributed in Germany, Italy, Spain (including Andorra), the Netherlands, Poland, Switzerland, Norway and Sweden.
Senseonics designed the Eversense E3 with proprietary sacrificial boronic acid (SBA) technology that enhances sensor longevity to make it what the company says is the longest-lasting CGM system. The sensor is fully implantable and requires just two sensor insertion and removal procedures per year.
The system also includes a removable smart transmitter, held in place with a mild silicone-based adhesive, offering discreet, on-body vibratory alerts and data transmission to a mobile app where users can view glucose values, trends and alerts.
Data presented in 2021 demonstrated strong accuracy with the fully implantable, 180-day sensor. Eversense E3 matched performance levels compared to the 90-day version, but with calibration reduced to essentially once per day. In studies, the sensor has produced a mean absolute relative difference (MARD) of 8.5%, representing high accuracy.
“The CE Mark approval for E3 is another demonstration of our commitment to advancing implantable CGM to improve the lives of more diabetes patients worldwide. Not only does E3 strengthen our position in the market, but it enables increased operational efficiency as Senseonics will now commercialize the same product iteration globally for the first time,” Senseonics President and CEO Tim Goodnow said in the release. “We are excited for Ascensia to continue to build on the momentum of the E3 launch in the U.S. as they commercialize the improved system in European markets in the coming months.”